BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    WINDMERE WAND MASSAGER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ZIEHM VISION RFD

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUCAM CONCEPT IV FWT, MODEL 110-0185G1

    FDA 510(k)
    FDA Class 1 ·Dental

    PUMP MMT-515LNAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 14, 2010

    ARGON PICC LINE

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL·Product code FOZ·January 22, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2014

    AMBIT ELECTRONIC PAIN CONTROL PUMP

    FDA Adverse Event
    Malfunction ·SUMMIT MEDICAL PRODUCTS, INC.·Product code FRN·October 15, 2020

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013